device · product 1 of 1
OT1000 Series Orthopedic Surgical Tables
- Recall number
- Z-1149-2021
- Initiated
- January 21, 2021
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Steris Corporation
- Quantity
- 272 tables total (Domestic: 227 tables, Foreign 45 tables)
App-derived interpretation
On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
Reason for recall
On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.
Code information
Model No.: OT1000, OT1100, OT1200
Distribution pattern
Domestic: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL IN, IW, KS, KY, LA, ME, MD, MI, MN, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, PR, SC, TX, UT, VT, VA, WA, WV, WI. Foreign: Canada, South Korea, Panama, Qatar, Thailand.